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Center
for Drug Evaluation &
Research (CDER) News
Drug Approvals -
Meetings
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Links |
Center
for Biologics Evaluation
&
Research (CBER)
Meetings
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Links |
Center
for Device &
Radiological
Health (CDRH)
Meetings
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Links |
Federal Register -
Meetings, Notices, & Rule Changes |
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January 23,
2010
January 22,
2010
-
FDA
issues
the
following
letters:
January 21,
2010
January 20,
2010
January 19,
2010
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January 22, 2010
- Ampicillin Sodium Injection, ACIC Fine Chemicals, Inc., Approval
- Finasteride Tablets, Zydus Pharmaceuticals, Approval
- Fluvastatin Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
- Gemcitabine Injection, Actavis Totowa, LLC, Tentative Approval
- Ibandronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
- Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Tentative Approval
- Latanoprost Ophthalmic Solution, Apotex, Inc., Tentative Approval
- Nicardipine Hydrochloride Injection, Bedford Laboratories, Approval
January 21, 2010
- Amlodipine and Valsartan Tablets, Matrix Laboratories Ltd., Tentative Approval
- Cefuroxime Sodium, Injection, Samson Medical Technologies, Approval
- Ergocalciferol Capsules, Sun Pharmaceutical Industries, Inc., Approval
- Gabapentin Capsules, InvaGen Pharmaceuticals, Approval
- Metformin Hydrochloride Extended-Release Tablets, Torrent Pharmaceuticals Ltd., Approval
- Miconazole Nitrate Vaginal Cream, Perrigo R&D Company, Approval
- Oxaliplatin Injection, Actavis Totowa, Tentative Approval
- Promethazine Hydrochloride Syrup, Amneal Pharmaceuticals, Approval
- Solodyn (minocycline hydrochloride) Extended-Release Tablets, Medicis Pharmaceutical Corporation, Labeling Revision
January 20, 2010
- Amlodipine Besylate and Benazepril Hydrochloride Capsules, Cobalt Laboratories Inc., Tentative Approval
- Aristocort (triamcinolone diacetate) Injection, Sandoz Inc., Labeling Revision
- Cardura (doxazosin mesylate) Tablets, Pfizer, Inc., Labeling Revision
- Cefuroxime Sodium in Plastic Container (cefuroxime sodium) Injection, Samson Medical Technologies, Approval
- Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Estradiol Valerate Injection, PharmaForce, Inc., Approval
- Gemcitabine Injection, Pliva Lachema, Tentative Approval
- Hydrochlorothiazide Capsules, Unichem Laboratories Ltd., Approval
- Indocin (indomethacin sodium) Injection, Lundbeck Inc., Labeling Revision
- Memantine Hydrochloride Tablets, Lupin Ltd., Tentative Approval
- Oxaliplatin Injection, Pliva Lachema, Approval
- Toprol-XL (metoprolol succinate) Extended-Release Tablets, AstraZeneca LP, Labeling Revision
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- FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB)
- Indexing Labeling for Human Drug and Biological Products using Structured Product Labeling (SPL). February 2010.
- FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD. Meeting Information and registration
- DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration
- 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration
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Guidance
Approved Drugs
Approval Process
Electronic Submissions
Firm Registration Status
Good Manufacturing Practice
Regulations
National Drug Code Directory
MedWatch: Adverse Event
Reporting
Download Forms
Generic Drugs
Small Business
En
Espaρol
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About CBER
CBER Vision & Mission
Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance
News & Events (Biologics)
What's New, Meetings & Workshops
CBER Reports
CBER Annual Report, Performance, FDAMA, PDUFA, FDAAA, PREA
Biologics Regulated Products
Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation
Contacts in the Center for Biologics Evaluation & Research (CBER)
Consumer questions, manufacturer's assistance, media inquiries, technical questions, requesting speakers, establishment registration...
Jobs at the Center for Biologics Evaluation and Research (CBER)
Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
Biologics Electronic Reading Room (eFOI)
Documents frequently requested through the Freedom of Information Act.
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January 20, 2010
January 19, 2010
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The A to Z of Off Label
Issues, February 9, 2010
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Public Meeting:
Incorporation of New
Science Into Regulatory
Decision-making Within
the Center for Devices
and Radiological Health
- February 9, 2010
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510(k) Submissions - The
Course for Beginning RA
Professionals for
Preparing a 510(k),
February 22-23, 2010
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Investigational Device
Exemption (IDE)
Submission Workshop,
February 24, 2010
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PMA Submissions
Workshop, February
25-26, 2010
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FDA/CDRH Public Meeting:
Blood Glucose Meters -
March 16-17, 2010
-
Forum for International
Medical Device
Regulatory Authorities,
May 3-6, 2010
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Guidance Documents (Medical Devices)
How to Market Your Device
Postmarket Requirements (Devices)
Importing and Exporting Devices
International Information (Devices)
Device Classification
Bioresearch Monitoring
FDA eSubmitter
CDRH Learn
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RULES
- NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
37383739 [20101153]
[TEXT] [PDF]
37353736 [20101154]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
International Conference on
Harmonisation:
Guidance on M3(R2) Nonclinical Safety Studies for the
Conduct of Human Clinical
Trials and Marketing
Authorization for
Pharmaceuticals;
Availability
34713472 [20101027]
[TEXT] [PDF]
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RULES |
New Animal Drugs; Change of
Sponsor's Name and Address
3159 [2010930]
[TEXT] [PDF]
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NOTICES |
Draft Guidance for Industry
and Food and Drug
Administration Staff:
Heart Valves Investigational Device Exemption and
Premarket Approval
Applications; Availability
3238 [2010990]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Advisory Committees; Filing
of Closed Meeting Reports
28642865 [2010807]
[TEXT] [PDF]
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
28652866 [2010782]
[TEXT] [PDF]
28672868 [2010783]
[TEXT] [PDF]
28662867 [2010790]
[TEXT] [PDF]
28682869 [2010791]
[TEXT] [PDF]
28742875 [2010792]
[TEXT] [PDF]
28692871 [2010793]
[TEXT] [PDF]
28722874 [2010794]
[TEXT] [PDF]
28712872 [2010795]
[TEXT] [PDF]
2871 [2010796]
[TEXT] [PDF]
Meetings:
Endocrinologic and Metabolic Drugs Advisory Committee
28752876 [2010785]
[TEXT] [PDF]
Vaccines and Related Biological Products Advisory
Committee
2876 [2010789]
[TEXT] [PDF]
Use of Tobacco Marketing
Descriptors to Convey
Modified Risk; Request for
Comments
2879 [2010784]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
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January 2010
- January 22, 2010 -
FDA Schedules Public Meeting on Premarket Clearance Process for Medical
Devices
- January 22, 2010 -
FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
- January 20, 2010 -
FDA Approves Left Ventricular Assist System for Severe Heart Failure
Patients
- January 19, 2010 -
U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in
Connection with Unlicensed Cosmetic Treatments
- January 18, 2010 -
FDA Warns Consumers about Counterfeit Alli
- January 15, 2010 -
FDA Commissioner Addresses Nation's Health Care Professionals on H1N1
Vaccine Safety
- January 15, 2010 -
U.S. Attorney New Release: Anesthesiologist Charged With Falsifying Medical
Research
- January 14, 2010 -
FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and
Distributed by Merrick Pet Care
- January 14, 2010 -
FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
- January 13, 2010 -
FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 &
Stage 2 Baby Foods
- January 13, 2010 -
U.S. Attorney News Release: Longmont, Colorado Man Arrested For Removing And
Replacing Labels On Gatorade Bottles
- January 12, 2010 -
FDA Unveils First Phase of Transparency Initiative
- January 11, 2010 -
FDA Approves New Drug for Rheumatoid Arthritis
- January 08, 2010 -
FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety
Monitoring System
- January 08, 2010 -
FDA Ends Maryland Seafood Processors Pattern of Sanitary Violations
- January 08, 2010 -
FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
- January 06, 2010 -
FDA Seizes More Than $1 Million Worth of Food from Nashville Food Processor
and Warehouse: Agency acts to prevent distribution of food from
rodent-infested facility
- January 04, 2010 -
FDA Takes Action Against New Jersey Cheese Manufacturer
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